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| ID | Type | Description | Link |
|---|---|---|---|
| URC 071006MED |
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Probiotics are friendly bacteria normally present in food products like yogurt whereas irritable bowel syndrome is a longstanding functional disorder characterized by abdominal pain and altered bowel habits either diarrhea or constipation dominant without a definitive etiology.
Study Hypothesis:Does probiotics(Saccharomyces boulardii improves daily bowel symptoms and quality of life in patients with diarrhea dominant irritable bowel syndrome?
Irritable bowel syndrome (IBS) is a common functional disorder and may lead to impaired social and personal function and can diminish quality of life.While the precise pathophysiology of IBS remains to be elucidated, dysmotility and altered visceral sensory perception are currently the most popular hypothesis. There has been a suggestion that some patients with IBS may harbor bacterial overgrowth leading to low grade inflammation, immune activation, and their symptoms may be ameliorated by its eradication.Probiotics, defined as live or attenuated bacteria or micro organism that confer a significant health benefit to the host.
Trial protocol:
Phase 1: placebo BID (1 week),both arms Phase 2: Randomization by pharmacy, placebo vs. active drug (6 weeks) Phase 3: placebo BID (1 week), both arms
-III. Probiotics have been demonstrated to exert anti-inflammatory effects at mucosal surfaces by reducing mucosal inflammation, decreasing immune mediated activation of enteric motor and sensory neurons and modifying neural traffic between the gut and central nervous system.
Saccharomyces Boulardii is a probiotic yeast and its role for the treatment of IBS has not been extensively investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Receive active drug Saccharomyces boulardii 250mg twice a day for 8 weeks. |
|
| 2 | Placebo Comparator | Placebo will be given twice a day for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saccharomyces boulardii | Drug | 250mg, twice a day in sachets, for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Any Improvement in symptoms of number of bowel habits, urgency, straining,sense of incomplete evacuation, stool form (evaluated by Bristol stool form scale, abdominal pain and bloating/flatulence | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in quality of life in diarrhea dominant IBS by validated IBS-QOL questionnaire. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lubna Kamani, FCPS, MRCP | Contact | 9221-4864659 | lubna.kamani@aku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lubna Kamani, FCPS,MRCP | Aga Khan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology outpatients clinics,Aga Khan University hospital | Recruiting | Karachi | 74800 | Pakistan |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Methyl cellulose powder (low viscosity) |
| Drug |
twice a day sachets for 10 weeks |
|
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |